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Guidance for Industry
 
Submission of SummaryBioequivalence Data for ANDAs
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)May 2011Generics
 
 
 
Guidance for Industry
Submission of SummaryBioequivalence Data for ANDAs
 Additional copies are available from:Office of Communications Division of Drug Information, WO51, Room 2201Center for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993-0002Phone: 301-796-3400; Fax: 301-847-8714druginfo@fda.hhs.govhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)May 2011Generics
 
Contains Nonbinding Recommendations
 
i
TABLE OF CONTENTS
 
I.
 
INTRODUCTION.............................................................................................................1
 
II.
 
BACKGROUND...............................................................................................................2
 
III.
 
SUBMISSION OF ALL BIOEQUIVALENCE STUDIES...........................................2
 
A.
 
What Types of ANDA Submissions Must Include All BE Studies?..........................................3
 
B.
 
What Format Should Be Used for a Summary Report?............................................................3
 
IV.
 
SAME DRUG PRODUCT FORMULATION................................................................3
 
A.
 
Immediate-Release Drug Products...............................................................................................4
1. Immediate-Release Formulations Considered to Be the Same
……………………………..….4
 2. Immediate-Release Formulations Considered Not to Be the Same
……………………………5
3. Immediate-Release Formulations - Other 
………………………………………………..……
6
 
B.
 
Extended-Release Drug Products—Nonrelease Controlling Excipients...................................6
1. Extended-Release Formulations Considered to Be the Same
(Nonrelease Controlling Excipients)
…
6
 2. Extended -Release Formulations Considered Not to Be the Same
 (Nonrelease Controlling Excipients)
……………………………………………………………………...…..……….
7
3. Extended-Release Formulations - Other 
(Nonrelease Controlling Excipients)
………...………..……
7
 
C.
 
Extended-Release Drug Products—Release Controlling Excipients.........................................8
1. Extended-Release
 
Formulations Considered to Be the Same
(Release Controlling Excipients)
……..
8
 
2. Extended-Release Formulations Considered Not to Be the Same
(Release Controlling Excipients)
 ...
8
3. Extended-Release Formulations - Other 
(Release Controlling Excipients)
 ...
.......................................8D. Semisolid Dosage Forms................................................................................................................8E.
 
Other Complex Dosage Forms......................................................................................................9
 
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